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Randomized Controlled Trial
, 10 (3), e0119612
eCollection

Can Acupuncture Treatment Be Double-Blinded? An Evaluation of Double-Blind Acupuncture Treatment of Postoperative Pain

Affiliations
Randomized Controlled Trial

Can Acupuncture Treatment Be Double-Blinded? An Evaluation of Double-Blind Acupuncture Treatment of Postoperative Pain

Lene Vase et al. PLoS One.

Abstract

Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed "de qi" in East Asian medicine), and patients' pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015) for both patients and acupuncturists, indicating that the needles were not successful in double-blinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027), suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients' acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical trials in the assessment of acupuncture treatment.

Conflict of interest statement

Competing Interests: Nobuari Takakura (NT) and the Educational Foundation of Hanada Gakuen possess a U.S. patent 6575992B1 (patent title: Safe needle, placebo needle, and needle set for double blind), a Canadian patent CA 2339223 (patent title: Safe needle, placebo needle, and needle set for double blind), a Korean patent 0478177 (patent title: Safe needle, placebo needle, and needle set for double blind), a Taiwan patent 150135 (patent title: Safe needle, placebo needle, and needle set for double blind), a Chinese patent ZL00800894.9 (patent title: Safe needle, placebo needle, and needle set for double blind), a Hong Kong patent HK1036928 (patent title: Safe needle, placebo needle, and needle set for double blind), and a Japanese patent 4061397 (patent title: Placebo needle, and needle set for double-blinding). The safe needle is a penetrating needle and the placebo needle is a non-penetrating needle as illustrated and described in this paper. The needle set is a pair of penetrating needles and non-penetrating needles for use in double-blind acupuncture studies. NT is a salaried employee of the Educational Foundation of Hanada Gakuen and has received research funding from the Educational Foundation of Hanada Gakuen. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Active and placebo needles.
Each needle assembly comprises an opaque guide tube (1) and upper stuffing (2) to provide resistance to the needle body during its passage through the guide tube. The body of the penetrating needle (3) is longer than the guide tube by an amount equal to the insertion depth, but the body of the non-penetrating needle (4) is only long enough to allow its blunt tip to press against the skin when the needle body is advanced to its limit. The non-penetrating needle contains stuffing at the bottom as well (5) to give a sensation similar to that of skin puncture and tissue penetration. Both needles have a stopper (6) that prevents the needle handle (7) from advancing further when the sharp tip of the penetrating needle (8) or the blunt tip of the non-penetrating needle (9) reaches the specified position. The pedestal (10) on each needle is adhesive, allowing it to adhere firmly to the skin surface. The diameter of the needles used in this study was 0.16 mm.
Fig 2
Fig 2. Acupuncture points.
The five acupuncture points.
Fig 3
Fig 3. Study design.
Patients who developed pain levels of ≥ 3 (0–10) up to 4 hours following surgical removal of one mandibular third molar were randomized to receive active acupuncture (AA) or placebo acupuncture (PA) for 30 minutes. Pain levels were measured at pretreatment, halfway through the session, and at the end of the session. Needles were rotated during insertion, halfway through the session, and at the end of the session right before they were removed. The patients and the acupuncturist were asked about the experience of de qi right after insertion of the needle and at the end of the study, respectively. Both the patients and the acupuncturist reported perceived treatment allocation at the end of the study.

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Publication types

Grant support

Lene Vase is part of the Europain Collaboration, which has received support from the Innovative Medicines Initiative Joint Undertaking, under grant agreement no. 115007, the resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ kind contribution, www.imi.europa.eu. The funding source had the possibility to comment on the design and the reporting of the study, but had no role in the collection, analysis, and interpretation of the data and the decision to submit for publication.
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